Intermittent Fasting for Brain Health

Overseen By Ana Clara da Costa Pinaffi Langley, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Oklahoma

Must not be taking: Sulfonylureas, Meglitinides, Insulin

Disqualifiers: Active CNS disease, Major psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The central hypothesis of this study is that closer adherence to time restricted eating (TRE) will improve endothelial function, neurovascular (NVC) responses, resulting in improved cognitive performance, potentially through activation of SIRT1-dependent vasoprotective pathways.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are diabetic and taking certain medications like sulfonylureas, meglitinides, or insulin, you cannot participate in the trial.

Is intermittent fasting safe for humans?

Research on alternate-day fasting, a type of intermittent fasting, shows it is generally safe for weight loss in both obese and non-obese individuals, with no major safety concerns reported. However, more studies are needed to fully understand its long-term effects on health beyond weight loss. ^{1 2 3 4 5}

How does intermittent fasting differ from other treatments for brain health?

Intermittent fasting is unique because it involves alternating periods of eating and fasting, which can lead to changes in brain function through metabolic, cellular, and circadian mechanisms. Unlike traditional treatments that may focus on medication or supplements, intermittent fasting leverages the body's natural processes to potentially improve brain health and cognitive function. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Intermittent Fasting for brain health?

Research shows that intermittent fasting may have benefits for brain health, particularly in conditions like epilepsy, Alzheimer's disease, and multiple sclerosis, by improving disease symptoms and progress. Animal studies suggest potential benefits for other brain-related disorders, but more human studies are needed to confirm these effects. ^{1 7 8 9 11}

Who Is on the Research Team?

Andriy Yabluchanskiy, MD, PhD

Principal Investigator

University of Oklahoma

Are You a Good Fit for This Trial?

This trial is for individuals aged between 55 and 80 who can read, write, and understand English. They should be mentally competent to consent and have a Mini-Mental State Exam score of at least 24. It's not suitable for those with major psychiatric diseases, uncontrolled substance abuse issues, certain diabetics on specific medications, or anyone with recent severe brain-related health events.

Inclusion Criteria

Ability to read and write in English

You have a score of 24 or higher on a test that measures your thinking and memory abilities.

I can see and hear well enough to take part in exams.

Exclusion Criteria

You have difficulty seeing or hearing, which would make it hard for you to complete the study assessments.

I have not had a stroke, except for a TIA, in the last 60 days.

I am diabetic and take sulfonylureas, meglitinides, or insulin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants adhere to a time restricted eating schedule with a 10-hour eating window each day

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intermittent Fasting

Trial Overview The study tests if sticking closely to intermittent fasting (eating within a set time frame each day) improves brain function in older adults. The focus is on whether this eating pattern enhances cognitive abilities by improving blood vessel function in the brain through certain protective pathways.

How Is the Trial Designed?

Group I: Time restricted eating Experimental Treatment 1 Intervention

not more than 10 hrs. eating window daily goal for 6 months

Who Is Running the Clinical Trial?

University of Oklahoma

Lead Sponsor

Trials

484

Recruited

95,900+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

Intermittent fasting, particularly alternate-day fasting, has been shown to effectively reduce body weight by approximately 3%-7% and body fat by about 3-5.5 kg over periods of 3 to 12 weeks in various populations, including normal-weight, overweight, and obese individuals.

Whole-day fasting lasting 12 to 24 weeks also leads to significant reductions in body weight (≈3%-9%) and improvements in blood lipids, with total cholesterol decreasing by 5%-20% and triglycerides by 17%-50%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of intermittent fasting on body composition and clinical health markers in humans. Tinsley, GM., La Bounty, PM.[2018]

A systematic review identified only three randomized controlled trials on fasting in humans, all showing improvements in surrogate outcomes like weight and cholesterol, but no trials focused on actual clinical events like diabetes or coronary artery disease.

While some observational studies suggest fasting may lower the prevalence of conditions like coronary artery disease and diabetes, the overall lack of rigorous clinical trials means more research is needed before fasting can be confidently recommended as a health intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health effects of intermittent fasting: hormesis or harm? A systematic review. Horne, BD., Muhlestein, JB., Anderson, JL.[2023]

Intermittent fasting (IF) has shown potential benefits for brain health and cognitive function, particularly in animal models, but there is currently no clear evidence of short-term cognitive improvements in healthy humans.

Clinical studies suggest that IF may help manage symptoms and progression of brain disorders such as epilepsy, Alzheimer's disease, and multiple sclerosis, indicating its potential as a therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effects of Intermittent Fasting on Brain and Cognitive Function. Gudden, J., Arias Vasquez, A., Bloemendaal, M.[2021]

Intermittent fasting, including methods like the 5:2 diet and time-restricted feeding, shows similar weight loss efficacy to standard daily calorie restriction, but many fasting models do not involve strict fasting cycles or complete fasting.

Longer fasting durations, particularly those extending beyond 16 hours, may enhance benefits like fat loss and improved insulin sensitivity, suggesting that the physiological effects of fasting could be more pronounced with sustained fasting periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of intermittent fasting and meal timing in weight management and metabolic health. Templeman, I., Gonzalez, JT., Thompson, D., et al.[2020]

Modified alternate-day fasting (ADF) led to significant weight loss (5.6 kg) and reduced body fat percentage in 16 obese adults over 8 weeks, demonstrating its efficacy as a weight management strategy.

ADF also improved cardiovascular health indicators, with notable reductions in total cholesterol, LDL cholesterol, and triglycerides, suggesting it may lower the risk of coronary artery disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term modified alternate-day fasting: a novel dietary strategy for weight loss and cardioprotection in obese adults. Varady, KA., Bhutani, S., Church, EC., et al.[2023]

In a study of 32 non-obese individuals over 12 weeks, alternate day fasting (ADF) led to a significant weight loss of 5.2 kg (6.5%) and a reduction in fat mass without affecting fat-free mass, indicating its efficacy for weight management.

ADF also improved cardiovascular risk factors, as evidenced by decreased triacylglycerol levels, increased LDL particle size, and changes in adipokine levels, suggesting potential cardio-protective benefits in normal weight and overweight adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternate day fasting for weight loss in normal weight and overweight subjects: a randomized controlled trial. Varady, KA., Bhutani, S., Klempel, MC., et al.[2021]

A study is being conducted to explore the effects of alternate day fasting (ADF) on healthy non-obese individuals, involving 90 participants, with some having followed ADF for at least 6 months and others starting ADF for 4 weeks.

The research aims to assess various health parameters, including metabolic and cardiovascular effects, using advanced techniques like echocardiography and glucose monitoring, to better understand the physiological impacts of ADF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Fasting (Alternate Day Fasting) in Healthy, Non-obese Adults: Protocol for a Cohort Trial with an Embedded Randomized Controlled Pilot Trial. Tripolt, NJ., Stekovic, S., Aberer, F., et al.[2022]

In an 8-week study with 59 obese participants, alternate day fasting (ADF) led to a significant weight loss of 4.2%, while only a small percentage reported mild adverse effects like constipation and dizziness.

ADF was associated with improvements in eating disorder symptoms, including a decrease in depression and binge eating, suggesting that it may have beneficial effects on body image and eating behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. Hoddy, KK., Kroeger, CM., Trepanowski, JF., et al.[2018]

Alternate-day fasting (ADF) is a safe and well-tolerated weight loss method, with 93% of participants completing the 8-week study without adverse effects.

While ADF and a standard caloric restriction diet produced similar weight loss results after 8 weeks, ADF showed more favorable changes in body composition, particularly in fat and lean mass, during the follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized pilot study comparing zero-calorie alternate-day fasting to daily caloric restriction in adults with obesity. Catenacci, VA., Pan, Z., Ostendorf, D., et al.[2019]

In a 12-month study involving 34 obese participants, those who lost 5% or more of their body weight on alternate-day fasting (ADF) reported feeling fuller and less hungry, indicating improved satiety.

Successful weight losers on ADF also increased their dietary protein intake from 15% to 20% of their total calories and showed better adherence to calorie goals on fasting days, suggesting effective behavioral changes associated with this diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eating behavior traits of successful weight losers during 12 months of alternate-day fasting: An exploratory analysis of a randomized controlled trial. Kroeger, CM., Trepanowski, JF., Klempel, MC., et al.[2020]

Alternate-day fasting (ADF) resulted in greater fat mass loss compared to very-low-calorie dieting (VLCD), with ADF showing a loss of 3.31 kg of fat mass, while VLCD had similar fat mass loss but with more overall weight loss and fat-free mass loss.

Despite ADF not leading to significantly more overall weight loss than VLCD, it may be easier for some individuals to stick to, making it a potentially more sustainable dieting method for fat loss while preserving muscle mass.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternate-day versus daily energy restriction diets: which is more effective for weight loss? A systematic review and meta-analysis. Alhamdan, BA., Garcia-Alvarez, A., Alzahrnai, AH., et al.[2021]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Effects of intermittent fasting on body composition and clinical health markers in humans. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Health effects of intermittent fasting: hormesis or harm? A systematic review. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Effects of Intermittent Fasting on Brain and Cognitive Function. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The role of intermittent fasting and meal timing in weight management and metabolic health. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Short-term modified alternate-day fasting: a novel dietary strategy for weight loss and cardioprotection in obese adults. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Alternate day fasting for weight loss in normal weight and overweight subjects: a randomized controlled trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Intermittent Fasting (Alternate Day Fasting) in Healthy, Non-obese Adults: Protocol for a Cohort Trial with an Embedded Randomized Controlled Pilot Trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

A randomized pilot study comparing zero-calorie alternate-day fasting to daily caloric restriction in adults with obesity. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Eating behavior traits of successful weight losers during 12 months of alternate-day fasting: An exploratory analysis of a randomized controlled trial. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Alternate-day versus daily energy restriction diets: which is more effective for weight loss? A systematic review and meta-analysis. [2021]